Clinical Research Directory

Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health (Healthy Heart - CKM)

The investigators are proposing a new team-based shared decision-making (SDM) program. The goal of this study is to see whether this program is practical and whether it may help adults with cardiometabolic risk factors and cardiovascular-kidney-metabolic syndrome. The investigators will enroll adults from a primary care clinic in Maryland. People in the intervention group will take part in the 6-month program in addition to usual care. People in the control group will receive usual care only.

Adaptation, Implementation, and Validation of an Innovative eHealth System for the Self-management, Monitoring, and Specialized Remote Medical Care of Patients With Diabetes in the Municipalities of Palermo (Huila) and Suárez (Cauca).

The study corresponds to a controlled, randomized, open-label clinical experiment approved by the Ethics Committee of Universidad Antonio Nariño, with the participation of clinical scientific personnel and technical support from Engineering. The study will include patients over 18 years of age with type 2 diabetes mellitus (T2DM) for at least one year, under follow-up at chronic patient care centers in Palermo, Huila, and Suárez, Cauca. Participants must have Glycosylated Hemoglobin (HbA1c) greater than 7%, i.e. HbA1c ≥7%, measured using BIOHERMES HbA1c, and receive insulin treatment with at least one daily application or have an indication for insulin treatment. In addition, they must have access to a mobile phone with data. Patients with, among other conditions, acute diabetes decompensation, recent history of myocardial infarction or acute coronary syndrome, glucocorticoid use, visual impairment or cognitive deterioration, proliferative retinopathy, amputations or severe peripheral neuropathy, pregnancy or breastfeeding, psychiatric disease, stage 4 or 5 kidney disease, or severe liver disease will be excluded. Potential patients will be identified among those who have been active for at least three months in chronic disease programs. After verifying the eligibility criteria, the study objectives will be explained and informed consent will be requested, including the right to voluntary withdrawal at any time. The study comprises a 14-day selection period and a 180-day treatment period. During selection, baseline clinical data, HbA1c, and incidence of hypoglycemia will be obtained. Subsequently, Participants will be assigned in a 1:1 ratio to the intervention and control groups using a computer-generated random sequence managed centrally by the study server, ensuring allocation concealment with no possibility of modification by the treating physicians. The study will consist of four visits V1, V2, V3 and V4, corresponding to days 0, 15, 105, and 195, respectively. The intervention group will use the eHealth system and will receive training according to the study protocol and user manual. Data recorded on the platform will be evaluated every two weeks by a physician trained in diabetes care, who may make therapeutic adjustments in the event of hypoglycemia or recurrent hyperglycemia, according to established protocols and the ACE 2024 clinical guideline. The system enables the acquisition of data from glucose meters, analysis through a web interface, and remote medical communication through a mobile application. The control group will receive usual care and capillary glucose self-monitoring, with in-person evaluations every three months and therapeutic adjustments according to established protocols. During the visits, blood pressure, weight, HbA1c, medications used, hypoglycemia episodes, home glucose measurements, periods without medication, hospitalizations, and symptoms associated with adverse events will be evaluated. The DTSQs (treatment satisfaction), ADDQoL19 (diabetes-dependent quality of life), and HypoSRQ (self-reported hypoglycemia) questionnaires will also be administered at baseline (V2), 3 months (V3), and 6 months (V4). At 6 months, the DTSQc (change in treatment satisfaction) will be added for both groups, and an adapted version of the Telehealth Usability Questionnaire (TUQ) will be administered to the intervention group. To control possible changes associated with the observation effect, physical activity will be monitored through daily step records and diet through nutritional training and calorie counting at baseline, three months, and six months. Data will be transferred in anonymized form and used exclusively for the research objectives, without commercial purposes. The sample size was calculated to detect a 0.5% reduction in HbA1c, with 80% statistical power, an alpha error of 0.05, and a standard deviation of one. A total of 42 patients per arm in each municipality was estimated and, considering a 10% loss to follow-up, a sample of 50 patients per arm in each municipality was established, for a total of 200 patients.

Real-world Canadian Retrospective Study Evaluating Longitudinal Semaglutide Use on Cardio-Kidney-Metabolic Outcomes

The goal of this study is to better understand the real-world effectiveness of semaglutide use on cardio-kidney-metabolic outcomes among adults with T2D and adults with obesity (without diabetes mellitus). This is a retrospective longitudinal analysis using the LMC Diabetes Registry. The primary outcome of the study is to evaluate the change in HbA1c between baseline to 3 years of follow-up among adults with T2D who initiated semaglutide compared to adults with T2D who initiated other AHAs, including sulfonylurea, dipeptidyl peptidase-4 inhibitors, and sodium-glucose cotransporter-2 inhibitors.

Integrating New Skills Into Diabetes Education With CGM

This study is designed to test the preliminary efficacy of a three-stage continuous glucose monitor (CGM) integration program for older adults who are taking insulin. This study will learn if a three-stage CGM integration program ("intervention") that includes sessions focused on CGM technology skills, data skills, and lifestyle skills impacts CGM wear-time, glycemic metrics, and participant-reported outcomes, compared to two standard CGM training approaches ("comparators"). Following a screening visit and baseline data collection, participants will be randomized to either the intervention or one of the two comparator arms for 6 weeks. The intervention involves three educational sessions over 4 weeks. The first session will be in-person and subsequent sessions will be virtual. Participants in the intervention may receive 1-2 additional individualized training sessions to review CGM skills. The first comparator (Comparator 1) will receive a one-time clinic-based CGM training. The second comparator (Comparator 2) will be provided with a comprehensive informational pamphlet about CGM. All participants will complete outcomes data collection at 6 weeks. The study will also explore participant experiences through a series of semi-structured interviews with a subset of purposively selected participants and their care partners to identify opportunities for scaling the intervention to a broader population. An extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention. Lastly, we will run an additional small sub-study where consented care partners of participants will attend the intervention or comparator sessions alongside the study participant and provide care partner-specific data.

Awareness of Bidirectional Relation of Diabetes Mellitus and Periodontal Health

The study will recruit patients having diabetes mellitus; where they will be asked to answer a questionnaire after obtaining an informed consent.

Role of Alpha-to-beta Cell Communication to Adapt Insulin Secretion to Insulin Resistance.

Glucagon secretion from α-cells has long been viewed as primarily a counterregulatory mechanism - e.g. an agent with a role to prevent blood sugar from decreasing to levels that compromise function. Our group, along with other researchers, have begun to identify a much more complex role for α-cells, raising questions about when and how glucagon may influence blood glucose levels. This proposal looks to detail proglucagon peptide secretion from α-cells and the impact this has on β-cell function and glucose tolerance, in preclinical studies of human islets and translational studies in human subjects. This protocol registration describes Aim 2 from this NIH grant which involves 2 study populations and separate protocols but addresses a common question. Aim 3 in the grant is focused on a separate hypothesis and will be conducted and published separately from Aim 2.

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Benefits of Retained Insulin for Good Health

The purpose of this research is to understand the impact of retained endogenous insulin (as measured by C-peptide) on quality of life and related outcomes in people living with insulin treated diabetes, and, in those living with type 1 diabetes, to determine the pragmatic and non-pragmatic C-peptide measures which have the strongest association with clinical benefit (including repeated home samples and derived measures of beta cell function). The investigators will do this in two ways: Firstly, the investigators will extend a large existing prospective study of new adult onset diabetes (Getting the Right Classification and Treatment From Diagnosis in Adults With Diabetes (StartRight)) https://clinicaltrials.gov/ct2/show/NCT03737799) which has followed 1800 participants for median 4 years from diabetes diagnosis. Participants with insulin treated diabetes will be invited to take part in a further research visit remotely or face to face. The investigators will assess the longitudinal relationship between C-peptide and the available quality of life, mental health status and healthcare utilisation measures over up to 9 years from diabetes diagnosis and assess additional measures in cross sectional analysis. In the second part of this research, the investigators will utilise cohorts of over 2500 participants with type 1 diabetes, measured C-peptide and consent to recontact to recruit 200 participants with a range of C-peptide. Eligible participants with C-peptide measured in clinical care may also be invited to take part. The investigators will undertake detailed assessment of complex and pragmatic measures of C-peptide and beta cell function and compare performance in predicting glycaemic outcomes (using data from continuous glucose monitors) and (where relevant) patient reported outcomes.

A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).

The Diabetes \& Equine Empowerment Program (DEEP) is a research study evaluating a novel diabetes education program that combines hands-on interactions with miniature horses and evidence-based diabetes self-management education for youth ages 8-20 years with diabetes. Participants and their caregivers attend four structured educational sessions led by a diabetes specialist and a certified equine specialist. Topics include diabetes self-management, coping skills, problem-solving, self-advocacy, and transition readiness. Researchers will evaluate whether the program is feasible to deliver, acceptable to participants and families, and helpful in supporting engagement in diabetes care. Participants will be followed for up to six months after the program, and study outcomes include satisfaction, diabetes-related distress, self-care behaviors, clinic attendance, and diabetes technology use. In simple terms, this study is exploring whether learning about diabetes through guided activities with miniature horses can help children, adolescents, and young adults feel more confident in managing their diabetes, improve self-care skills, and become more engaged in their health care. The goal is to determine whether this innovative educational approach is practical to offer and valued by patients, families, and health care providers.

Holistic CRM Care vs Standard of Care in a Primary Care Setting

Cardiovascular disease, high blood pressure, chronic kidney disease, and type 2 diabetes, collectively referred to as Cardio-Renal-Metabolic (CRM) conditions, are among the most common chronic diseases in society. In Sweden, approximately 2.5 million people live with high blood pressure, one million have impaired kidney function, and more than half a million live with diabetes or heart disease. Many individuals are affected by more than one of these conditions at the same time, meaning that up to 30% of patients registered at an average primary care practice belong to this group. These diseases are closely interconnected. Developing one condition substantially increases the risk of developing another, and the risk of cardiovascular events and other complications rises sharply as the number of diagnoses increases. As people live longer, it is becoming increasingly common for older adults to live with several chronic diseases simultaneously. This places a considerable burden on healthcare systems, both medically and economically. At the same time, there is strong evidence that early, coordinated interventions can slow disease progression and reduce the risk of future complications. Despite clear national guidelines, there is still room for improvement in clinical practice. One important reason is that healthcare services and treatment guidelines remain largely organized around individual diagnoses rather than around the overall needs of each patient. As a result, different specialists often work in parallel, sometimes pursuing different treatment goals and strategies. This can lead to both under-treatment and over-treatment, contributing to unequal care and unnecessary burden for patients. The CRM Centre at Danderyd Hospital provides an example of how integrated care can work in practice. There, assessment, treatment, and follow-up are delivered by a multidisciplinary team that takes the patient's entire disease profile into account. The model has produced promising results for patients with more complex medical needs. However, the vast majority of people with CRM-related conditions are managed within primary care. This study evaluates a new primary care model that builds on the experience gained from the CRM Centre at Danderyd Hospital. The aim is to bring together all patients with CRM diagnoses within a common care structure and a unified treatment strategy. Participating primary care centres will receive education and access to practical support materials that integrate recommendations from guidelines covering all three disease areas. An important component is strengthened collaboration between primary and specialist care. Participating centres will have opportunities for clinical observerships, multidisciplinary digital case conferences with specialists at Danderyd Hospital, and targeted consultations regarding patients with CRM conditions through the Department of Internal Medicine at Ersta Hospital. The project will be integrated into routine clinical practice without requiring additional patient visits. All patient management will be carried out by the responsible healthcare professionals, supported by the educational programme, clinical tools, and collaboration with specialist services. Using electronic health record data, national registers, and health economic analyses, the study will evaluate whether the model improves the use of evidence-based medications, increases achievement of treatment targets, and enhances cost-effectiveness. Long-term outcomes, including survival and rates of hospital admission, will also be assessed. By bringing together care from multiple perspectives, this project addresses a clear and growing clinical need: providing patients with CRM conditions with more coordinated, effective, and equitable care. The findings are expected to be directly applicable across primary care and could inform future models for managing multimorbidity on a broader scale.

Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App

The goal of this controlled pre-post-trial is to test the Accu-Chek SmartGuide continuous glucose monitoring (CGM) system and whether its predictive features provide additional benefits for adults with type 1 diabetes or insulin- treated type 2 diabetes. The main questions this study aims to answer are: * Does using the Accu-Chek SmartGuide together with the Predict App change participants' fear of hypoglycemia? * Does the Predict App affect other psychological and behavioral outcomes, such as sleep quality, confidence in preventing hypoglycemia, diabetes- related distress, and diabetes empowerment? * Does the use of the predictive features affect glucose levels and the way participants use and respond to CGM alarms and trend information? Participants will use the Accu-Chek SmartGuide for 6 weeks. During the first 2 weeks, participants will use the CGM system without the predictive features. During the following 4 weeks, participants will use the system together with the Accu-Chek SmartGuide Predict App. Participants will complete online questionnaires at two time points (after 2 and after 6 weeks) and answer short questions twice a day through a smartphone app during the first 2 weeks and the last 2 weeks of the study. CGM data will be collected throughout the study. A subgroup of 10 participants will also be invited to take part in an online interview about their experiences with the predictive features.

Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D

Feasibility study to evaluate the safety and feasibility of Omnipod automated insulin delivery algorithms in individuals with type 1 diabetes. This study will enroll up to 80 participants to have a minimum of 48 participants to initiate the use of Omnipod. The study will include hotel and outpatient evaluation periods.

Local and Systemic Inflammatory Bone Alterations Related to Dental Implant Survival.

Introduction: Dental implants offer a durable, aesthetic, and functional option for tooth replacement. However, they are not immune to failure. Current literature has highlighted the importance of systemic factors (such as vitamin D deficiency, osteoporosis and hypercolesterolemia) and local factors (such as the presence of nearby periapical infections or implant placement in sites with a history of endodontic failure) that affect bone health. Hypothesis: Bone alterations-whether systemic or local-represent a risk factor for implant failure and peri-implantitis. Objectives: To analyze implant failure and marginal bone loss in patients with local and/or systemic bone alterations compared to patients without such conditions. Methods: Implant failures occurring in patients treated within the Master's Program in Oral Medicine, Surgery, and Implantology at the University of Barcelona (MCIO-UB) over the last 10 years will be analyzed and correlated with bone factors (local and systemic) recorded in their medical histories. Cases lacking the radiographic and clinical data necessary to conduct the study will be excluded. Population: A total of 3,500 implants have been placed, with failure rates ranging from 4% to 8% depending on the techniques used; consequently, the study sample will consist of 192 implants. Cohorts of successful implants will be established by matching patients of the same sex and within a ±5-year age range who did not experience implant failure.

MiniMed Fit Payload Wear Pediatric Study

The purpose of this study is to assess MiniMed Fit Payload adhesive components in different wear locations over a 7-day period to support development of the future commercialized patch pump in participants 7-17 years of age.

An Innovative Proprioceptive Instrument for Upper Extremities

This study aimed to develop and validate an innovative proprioceptive assessment instrument for the upper extremities, the PropArm-PosiMoF (PropArm). This observational study was conducted in three stages. The first stage focused on the development and validation of PropArm, including test-retest reliability, concurrent validity, and convergent validity. The second stage established age norms and cut-off points in healthy adults. In the final stage, PropArm was applied to patients with proprioceptive impairments (stroke, shoulder impingement syndrome, and diabetes mellitus patients) to examine its diagnostic accuracy and clinical applicability.

Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes

This is a prospective, multicenter, randomized, double-blind, sham-controlled, adaptive study evaluating the pulsENDO system in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications (GLMs). The primary objective of this study is to demonstrate that pulsENDO therapy is superior to sham control for improving glycemic control in adults with type 2 diabetes.

Impact of Online Medical Misinformation

A cross-sectional analytical study was conducted among adult patients diagnosed with chronic diseases to assess the impact of online medical misinformation on medication adherence, treatment decision-making, and health care-seeking behavior.

Pilot RCT of a Chinese Medicine Diabetes Education Programme

The goal of this clinical trial is to learn if a Chinese medicine diabetes education programme is feasible and acceptable, and to explore its preliminary effects on self-management, for adults with type 2 diabetes in Hong Kong. The main questions it aims to answer are: 1. Is the Chinese medicine diabetes education programme feasible to deliver in a community setting (recruitment, retention and adherence)? 2. Is the programme acceptable to participants? 3. Does the programme show early signals of improving diabetes management self-efficacy and related outcomes? Researchers will compare the Chinese medicine education programme to usual care to see if the programme is feasible, acceptable and shows preliminary benefits. Participants will: 1. Be randomly assigned to either a 4-week Chinese medicine diabetes education programme (four group sessions, total 4-6 hours) or usual care 2. Complete assessments at baseline, after the programme, and at 2-month follow-up. 3. Attend a focus group interview at the end of the study (selected participants) Outcome assessors will be blinded to group allocation.

Impact of Food as Medicine Glycemic Control at Two Large Academic Medical Centers

The primary purpose of this study is to determine if the implementation of a food as medicine program would improve clinical outcomes when integrated into routine care at two large academic hospitals. 1. Determine if the FRESH Program's methods of addressing food insecurity improves clinical outcomes, reduces emergency room visits, and reduces hospital admissions for patients with diabetes, cardiovascular disease, surgery, and/or recent COVID-19 hospital admission. 2. Determine the feasibility and scalability of the FRESH Program nutrition intervention within two separate health systems in order to inform future state and federal policies governing reimbursement for nutritional interventions that improve food insecurity.

Studies of Insulin and Glucagon Action in the Liver

This study examines how glucagon works to regulate glucose metabolism, based on new findings that suggest glucagon signaling in the liver has more than one role, and that these multiple roles can be opposing in nature. Understanding this biology provides an opportunity to develop new generations of glucagon-based drugs that target specific pathways, making them more effective at controlling blood glucose. Participants will complete paired, 5-hour hyperinsulinemic glucose clamp visits in which they receive either glucagon or saline infusions while blood glucose is maintained and frequent blood samples are collected. The primary focus is whether coordinated glucagon and insulin signaling enhances hepatic insulin sensitivity.

Voice-activated and Touchscreen-controlled Smart Speaker Intervention for Older Adults With Poorly Controlled Type 2 Diabetes

This is a pre-post pilot study that will test the feasibility and acceptability of a health educator delivered diabetes education and skills training intervention using a voice-activated, touch screen controlled, smart speaker. We will enroll 30 adults aged 50 and older with poorly controlled type 2 diabetes as defined by a hemoglobin A1C of 8% in the study.

The NTU JO-SMART Study

This study recruits patients with coexisting obesity and knee osteoarthritis (KOA) to implement the NTU-JO Smart Program, an innovative intervention integrating AI-assisted community-based exercise with continuous glucose monitoring (CGM). The primary objective is to investigate whether this intervention can improve glycemic control in this comorbid population. Other outcome measures include the risk of total knee arthroplasty (TKA), body weight changes, pain intensity scores, bone mineral density (BMD), cognitive function, as well as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Patient-Reported Outcomes Measurement Information System (PROMIS) scores, which reflect the patients' overall functional status. The project also sought to explore the long-term association of the NTU-JO Smart Program with the development of type 2 diabetes (T2D) and major renal events, thereby facilitating patient-centered early treatment.

Determination of Resistance Training Status for Patients on Glucagon-Like Peptide-1 Receptor Agonists

This study examines how adults who take a GLP-1 receptor agonist medication (such as semaglutide \[Ozempic, Wegovy, Rybelsus\], liraglutide \[Saxenda, Victoza\], or tirzepatide \[Mounjaro, Zepbound\]) perform resistance (strength) training before and after starting their medication. GLP-1 medications are being prescribed more and more often to help people manage type 2 diabetes and lose weight. These medications work well, but a known side effect is that people can lose lean (muscle) tissue along with fat. Losing muscle can make it harder to move, do everyday tasks, and stay strong as we age. Resistance training, things like lifting weights, using resistance bands, or doing push-ups and squats, is the most effective way to keep and build muscle. Yet most adults in the United States do not meet the recommended amount of resistance training, and very little is known about the resistance training habits of people who take GLP-1 medications. The purpose of this research is to systematically collect information from adults using GLP-1 medications so we can better understand: how often they do resistance training before and after starting the medication; what their sessions look like (frequency, duration, intensity, muscle groups); whether their resistance training is linked to how strong they feel and how well they can carry out daily activities; and what makes resistance training easier or harder while on a GLP-1 medication. Findings will help doctors, dietitians, exercise professionals, and researchers design better guidance and interventions to protect muscle mass, physical function, and quality of life in people using GLP-1 medications. Who can join: Adults 18 years or older who are currently taking a GLP-1 receptor agonist medication for type 2 diabetes, overweight or obesity, or weight management, and who have been on the medication for at least three months at a stable dose. Participants must be able to read and respond to the survey in English. People who are pregnant or planning bariatric surgery within the next three months are not eligible. What participants will do: The study is a single, anonymous, online survey. Interested individuals click the survey link, review a short consent page, and indicate their willingness to participate. Eligible participants then answer questions about their background, current health, GLP-1 medication and dose, resistance training habits before and after starting the medication, self-reported strength and function, and things that make resistance training easier or harder. There are no in-person visits, no exercise tests, and no blood draws. How long it takes: About 10 minutes total, in one online session. There is no follow-up after the survey and no compensation is offered. Data privacy: The survey is anonymous. No names, email addresses, or IP addresses are collected or linked to responses. The survey runs on Qualtrics, a secure, institution-approved platform hosted on Ohio State University servers. The research team hopes to enroll up to 200-300 adults across the United States.

Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City

In this study, individuals living with diabetes in the Birmingham area will participate in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center, at a local faith-based organization. DSMES sessions meet twice a month and typically address topics including physical activity, nutrition, coping, and reducing risk and complications. Prior to beginning the program, participants will complete a questionnaire that assesses diabetes self-management behaviors (such as diet, physical activity, and medication adherence) and diabetes knowledge. Additionally, they will participate in a biometric screening where clinical data such as blood A1C, blood pressure, blood cholesterol, and BMI are collected. This data will also be collected again after the completion of the program. In this program, participants will be assigned a community health worker who will contact them outside of scheduled DSMES sessions to provide support. Participants will also be randomly assigned to one of two cohorts, the Traditional cohort and the Remote Patient Monitoring (RPM) cohort. The traditional cohort will use paper trackers to track blood pressure and blood sugar outside of DSMES sessions while the RPM cohort will utilize an RPM platform to track this data.